Results of Medtronic-Supported implantable cardioverter-defibrillator (ICD) Clinical Trial

MVP® (Managed Ventricular Pacing), exclusive programming on Medtronic pacemakers, which is proven to be effective in reducing unnecessary pacing in pacemaker patients, was applied in the MVP Trial of implantable cardioverter-defibrillator (ICD) patients. Data from MVP trial, sponsored by Medtronic, Inc., were presented today as a late breaking clinical trial at Heart Rhythm 2009, the annual scientific sessions of the Heart Rhythm Society.

MVP dramatically reduces unnecessary right ventricular pacing, meaning it does not deliver low-level pacing pulses to the heart when it is beating normally.

The trial aimed to establish whether atrial-based, dual chamber, managed ventricular pacing set at 60 beats per minute (MVP mode) is equivalent or superior to standard ventricular pacing settings of 40 beats per minute in ICD patients. The primary endpoint combined all-cause mortality and heart failure hospitalizations. An independent Data Monitoring Committee recommended early closure of the trial when it was determined that there would not be conclusive results in evaluation of the study’s primary objective. Analysis of the trial’s secondary objectives showed that with programming the ICD to MVP mode, fewer patients developed the need for pacing than those whose devices were programmed with standard ventricular pacing.

“Strong clinical evidence supporting the positive outcomes that MVP can have in pacemaker patients already exists,” said Marshall Stanton, M.D., vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. “The analysis presented today shows that MVP reduces the development of the need for pacing in some ICD patients, but there is no evidence to show atrial pacing improves outcomes among this group of ICD patients.”

In SAVE PACe, a previous trial of pacemaker patients published in The New England Journal of Medicine, use of Medtronic MVP or Search AV+ modes was proven to dramatically reduce unnecessary right ventricular pacing. This reduction was shown to reduce the development of persistent atrial fibrillation, which is an electrical malfunction of the upper chambers of the heart (atria) that can lead to irregular heartbeats. It is the most common side effect of pacemakers; the condition can cause stroke or death.

Source: Medtronic

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